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德谷门冬双胰岛素对比双相门冬胰岛素30治疗2型糖尿病疗效及安全性评价的荟萃分析
作者:史雨清  杨昱  王苏  朱航毅  王昆 
单位:南京医科大学附属江宁医院 内分泌科, 江苏 南京 211100
关键词:德谷门冬双胰岛素 双相门冬胰岛素30 2型糖尿病 荟萃分析 
分类号:R587.1
出版年·卷·期(页码):2022·41·第二期(176-182)
摘要:

目的:系统评价德谷门冬双胰岛素(IDegAsp)对比双相门冬胰岛素30(BIAsp 30)治疗2型糖尿病(T2DM)的疗效及安全性。方法:检索PubMed、Embase、The Cochrane Library、Clinical Trials、知网、万方及维普数据库,搜集比较IDegAsp与BIAsp 30治疗T2DM疗效与安全性的随机对照试验(RCTs)研究结果,检索时限均从建库至2021年4月10日。采用RevMan 5.4和Stata 14.0统计软件进行荟萃分析。结果:纳入7项RCT研究,共计2 256例受试者。荟萃分析结果显示,IDegAsp在改善空腹血糖水平(MD=-1.30, 95%CI为-1.50~-1.09,P<0.01)、降低终点日均胰岛素使用剂量(MD =-0.15,95%CI为-0.19~-0.11,P<0.01) 方面均优于BIAsp 30,但两组治疗后糖化血红蛋白及体重变化差异均无统计学意义(P>0.05)。IDegAsp组夜间低血糖发生率明显低于BIAsp 30组(RR=0.61,95%CI为0.52~0.71, P<0.01),但两组总体低血糖事件风险及总体不良事件风险之间的差异均无统计学意义(P>0.05)。结论:相比于BIAsp 30,IDegAsp能够更显著地降低T2DM患者的空腹血糖水平、胰岛素使用剂量以及夜间低血糖事件发生的风险,且不会增加体重和总体不良事件发生风险。

Objective: To systematically review the efficacy and safety of insulin degludec/insulin aspart(IDegAsp) versus biphasic aspart 30(BIAsp 30) in the treatment of type 2 diabetes mellitus(T2DM). Methods: Databases including PubMed, Embase, The Cochrane Library, Clinical Trials, CNKI, Wanfang and VIP were searched for randomized controlled trials(RCTs), comparing the efficacy and safety of IDegAsp versus BIAsp 30 in the treatment of T2DM from inception to April 10,2021. The Meta-analysis was performed by RevMan 5.4 and Stata 14.0. Results: Seven RCTs with 2 256 participants were included. The Meta-analysis showed that IDegAsp was superior to BIAsp 30 in reducing the level of fasting plasma glucose(FPG)(MD=-1.30, 95%CI-1.50-1.09,P<0.01) and end-point daily average insulin dosage(MD=-0.15, 95%CI -0.19-0.11, P<0.01), however, the difference between IDegAsp and BIAsp 30 in the change of glycosylated hemoglobin(HbA1c) and body weight from baseline was not statistically significant(P>0.05). The incidence of nocturnal hypoglycemic in IDegAsp was significantly lower than that in BIAsp 30(RR=0.61, 95%CI 0.52-0.71,P<0.01),but there was no significant difference between IDegAsp and BIAsp 30 in the incidence of overall severe hypoglycemia and adverse events. Conclusion: Compared with BIAsp 30, IDegAsp can significantly reduce FPG, insulin dosage and the incidence of nocturnal hypoglycemic, which will not increase the weight and the overall risk of adverse events.

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